Behavioral Activation for Cancer

(BALANCE Trial)

Overseen By Krina C Durica

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Non-English speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

22 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Behavioral Activation for cancer patients?

Research shows that Behavioral Activation (BA) can improve the quality of life and emotional state of lung and breast cancer patients during chemotherapy by encouraging them to engage in rewarding activities and reduce avoidance behaviors. This approach has been effective in managing depression and anxiety, which are common emotional challenges faced by cancer patients. ^{1 2 3 4 5}

Is Behavioral Activation safe for cancer patients?

Behavioral Activation (BA) has been studied in cancer patients and appears to be a practical and safe intervention that can improve quality of life and emotional well-being during treatment. There is no evidence from the studies reviewed that suggests any safety concerns for cancer patients using BA. ^{1 2 3 4 6}

How is the treatment Behavioral Activation different from other treatments for cancer?

Behavioral Activation is unique because it focuses on encouraging cancer patients to engage in rewarding activities to improve their quality of life and emotional state during chemotherapy, unlike other treatments that may not address these aspects directly. ^{1 2 3 4 7}

What is the purpose of this trial?

The goal of this study is to learn if behavioral activation can improve daily quality of life for patients with advanced cancer. The main questions it aims to answer are: * Can behavioral activation be adapted to help patients living with advanced cancer optimize their daily quality of life? * Can behavioral activation be delivered primarily via smartphone? Participants will: * Complete a demographic questionnaire at the beginning of the study and quality-of-life and activity questionnaires at the beginning, midpoint, and end of study. Complete nightly surveys about daily quality of life, mood, activities, and experiences. * Wear a Fitbit activity tracker for 8 weeks. * After the first four weeks, they will complete a session with a member of our team about their day-to-day activities, behaviors, and experiences. They will select at least 4 activities/behaviors to increase over the next portion of the study. * Incorporate personalized meaningful activities into daily life * At the end of approximately eight weeks, (four weeks after the session with a study team member), they will complete a semi-structured interview.

Research Team

Carissa A Low, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for patients with advanced cancer who are interested in improving their daily quality of life. Participants need to be willing to use a smartphone and wear a Fitbit tracker, complete questionnaires, and engage in personalized activities as guided by the study.

Inclusion Criteria

Owns and uses a smartphone capable of running study applications

I have Stage IV cancer and am getting treatment at a UPMC Hillman Cancer Center.

Exclusion Criteria

I cannot read, write, or speak English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Data Collection

Participants complete baseline questionnaires and are oriented to the study procedures, including installing the BALANCE app and wearing a Fitbit.

4 weeks

1 visit (in-person or online)

Mid-Study Data Review

Participants review their data with a team member and select activities to increase for the next phase.

1 week

1 visit (in-person or online)

Data-Based Intervention

Participants engage in behavior change activities, receive daily reminders, and complete surveys.

4 weeks

Follow-up

Participants complete a semi-structured interview and end-of-study questionnaire.

1 week

1 visit (in-person or online)

Treatment Details

Interventions

• Behavioral Activation

Trial Overview The study tests whether behavioral activation can enhance day-to-day living for those with advanced cancer. It involves tracking activity via Fitbit, completing surveys on mood and quality of life, and adapting daily behaviors through guidance over an 8-week period.

Participant Groups

Group I: Activity tracking via smartphone app Experimental Treatment 1 Intervention

Participants will rate their day and indicate activities they did that day via the smartphone once each evening for the first four weeks. After four weeks, they will complete a mid-study data review session with a study team member about the activities, behaviors, and experiences they believe are most strongly related to their day-to-day quality of life. For the last 4 weeks of the study, they will select at least 4 behaviors or activities to increase. Participants will fill out morning surveys to plan an activity, receive daily reminders through the BALANCE app to support behavior change, and complete evening surveys to report daily quality of life and indicate completed activities.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Findings from Research

This study is the first randomized controlled trial examining the effectiveness of a behavioral activation (BA) program specifically for treating depression in patients with advanced cancer, involving 38 participants across three sites in Japan.

The primary outcome measure is the Beck Depression Inventory-II (BDI-II) score, and the results are expected to provide evidence for BA as a feasible and acceptable intervention to improve mood and quality of life in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation for depression in patients with advanced cancer: study protocol for a multicenter randomized controlled trial. Hirayama, T., Ogawa, Y., Ogawa, A., et al.[2023]

Behavioral activation (BA) significantly improves the quality of life and emotional well-being of lung and breast cancer patients undergoing chemotherapy, as shown in a study with 50 lung cancer patients and 33 breast cancer patients in the experimental group.

The intervention helps patients maintain rewarding activities, which can enhance their social and role functioning while reducing avoidance behaviors, demonstrating BA as a practical approach during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Behavioral Activation on the Quality of Life and Emotional State of Lung Cancer and Breast Cancer Patients During Chemotherapy Treatment. Fernández-Rodríguez, C., Villoria-Fernández, E., Fernández-García, P., et al.[2020]

Both Behavioral Activation (BA) and Acceptance and Commitment Therapy (ACT) are effective treatments for emotional problems in cancer survivors, as shown in a study of 52 patients, where both therapies outperformed a waiting list control group.

ACT was found to be more effective than BA in reducing social impairment and avoidance/rumination, indicating that these mechanisms play a key role in improving emotional well-being among cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating anxiety and depression of cancer survivors: Behavioral activation versus acceptance and commitment therapy. González-Fernández, S., Fernández-Rodríguez, C., Paz-Caballero, MD., et al.[2018]

A retrospective review of 10 cancer patients undergoing behavioral activation therapy (BAT) showed a high completion rate (90%) and significant improvements in depression and anxiety scores, indicating BAT's potential effectiveness in this population.

Patients reported substantial reductions in depression (PHQ-9 scores decreased from 14.4 to 5.1) and anxiety (GAD-7 scores decreased from 11.9 to 4.7) after completing the program, suggesting that BAT can be a valuable non-pharmacological treatment option for managing mental health in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation therapy for depression and anxiety in cancer patients: a case series study. Hirayama, T., Ogawa, Y., Yanai, Y., et al.[2022]

Behavioral interventions play a crucial role in managing side effects of cancer treatments, particularly in reducing nausea and vomiting caused by chemotherapy, which is a primary focus of current research.

These interventions are also being applied to alleviate other distressing symptoms such as anxiety and pain in both adult and pediatric cancer patients, highlighting their importance in comprehensive cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in behavioral intervention in comprehensive cancer treatment. Redd, WH.[2019]

Behavioral science is crucial in cancer control, influencing all stages from prevention to terminal care, and can significantly enhance health outcomes through effective strategies like smoking cessation and cancer screening.

Implementing behavioral strategies could lead to substantial benefits, such as 7.2 million fewer smokers, 45,000 additional 5-year cancer survivors annually, and improved quality of life for 150,000 patients suffering from treatment side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral science in translational research and cancer control. Morrow, GR., Bellg, AJ.[2019]

Behavioral science is increasingly recognized as a crucial component in cancer control, contributing to prevention, early detection, and survivorship strategies.

The collaboration between behavioral and biomedical sciences is expected to enhance efforts in reducing cancer incidence and improving patient outcomes, highlighting the importance of interdisciplinary research in the fight against cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral oncology and the war on cancer: partnering with biomedicine. Stefanek, ME., Andrykowski, MA., Lerman, C., et al.[2009]

References

1. England pubmed.ncbi.nlm.nih.gov

Behavioral activation for depression in patients with advanced cancer: study protocol for a multicenter randomized controlled trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of Behavioral Activation on the Quality of Life and Emotional State of Lung Cancer and Breast Cancer Patients During Chemotherapy Treatment. [2020]

3. Spain pubmed.ncbi.nlm.nih.gov

Treating anxiety and depression of cancer survivors: Behavioral activation versus acceptance and commitment therapy. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Behavioral activation therapy for depression and anxiety in cancer patients: a case series study. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Advances in behavioral intervention in comprehensive cancer treatment. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Behavioral science in translational research and cancer control. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Behavioral oncology and the war on cancer: partnering with biomedicine. [2009]